Shanghai Pharmaceuticals Holding (02607): Approval for production of Ursodeoxycholic acid capsules at Changzhou Pharmaceutical Factory.

Shanghai Pharmaceuticals Holding (02607) announced that its holding subsidiary, Changzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as "Changzhou Pharmaceutical Factory"), has received the Drug Registration Certificate (Certificate Number: 2025S00209) issued by the National Medical Products Administration for its Ursodeoxycholic Acid Capsules (250mg). The drug has been approved for production. Ursodeoxycholic Acid Capsules are mainly used to treat cholesterol gallstones in the gallbladder - the stones must be X-ray penetrable, and the gallbladder contraction function must be normal; cholestasis liver disease (such as primary biliary cirrhosis); and bile reflux gastritis. The researching company for Ursodeoxycholic Acid Capsules is Dr. Falk Pharma GmbH, and the product was launched in Germany in March 1999 with a specifications of 250mg. In June 2023, Changzhou Pharmaceutical Factory Co., Ltd. submitted an application for registration and listing of the drug to the National Medical Products Administration, and it was accepted. As of the date of this announcement, the company has invested approximately RMB 12.15 million in research and development costs for this drug. According to national policies, generic drugs classified as newly registered will receive greater support in areas such as medical insurance payment and procurement by medical institutions. Therefore, the approval of the production of Ursodeoxycholic Acid Capsules by Changzhou Pharmaceutical Factory Co., Ltd. is beneficial for expanding the market share of the drug, enhancing market competitiveness, and accumulating valuable experience for the company's future generic drug applications.